Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
This guidance document clarifies the interplay between the European Union Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the Artificial Intelligence Act (AIA) for medical device manufacturers. Endorsed by the Artificial Intelligence Board and the Medical Device Coordination Group, it addresses frequently asked questions concerning the scope, classification, quality management, data governance, technical documentation, transparency, human oversight, conformity assessment, and post-market monitoring of medical device artificial intelligence.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
This document is primarily aimed at medical device manufacturers, notified bodies, and competent authorities navigating dual compliance under the MDR/IVDR and the AIA.
What the document contains
This document covers the joint application of the EU Artificial Intelligence Act and the Medical Devices/In Vitro Diagnostic Medical Devices Regulations. It provides answers regarding product classification, quality management systems, data governance, technical documentation, transparency, human oversight, clinical evaluations, conformity assessments, substantial modifications, and post-market surveillance for medical device artificial intelligence.
The document does not provide final binding interpretations of Union law, nor does it replace official European Commission horizontal guidelines or future implementing acts under development.
- The AIA complements the MDR and IVDR by introducing specific requirements to address health, safety, and fundamental rights risks unique to AI systems used in medical devices.
- An AI system embedded in a medical device is generally classified as high-risk under the AIA if it acts as a safety component or is itself a medical device subject to third-party conformity assessment under the MDR or IVDR.
- Manufacturers can integrate AIA quality management, risk management, and technical documentation requirements into their existing MDR/IVDR procedures to avoid duplication.
- High-risk Medical Device Artificial Intelligence (MDAI) requires robust data governance, transparency, clear human oversight mechanisms, and comprehensive post-market monitoring.
- Pre-determined changes assessed during initial conformity assessment do not constitute substantial modifications requiring a new conformity assessment under the AIA.
· I. Scope of application and classification · II. Requirements - 1. Management Systems - 2. Data Governance - 3. Technical Documentation - 4. Transparency and human oversight - 5. Accuracy, Robustness and Cybersecurity · III. Clinical /Performance Evaluation and Testing · IV. Conformity assessment · V. Substantial Modification/significant change · VI. Post-market monitoring · VII. Other questions
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Fairness
4/5Non-discrimination and equitable treatment
The AIA requires high-risk MDAI manufacturers to implement data governance and management practices appropriate for the claimed intended purpose, including with a view of possible biases
2. Data Governance
screening score · 2026-10-23
Human Dignity
2/5Respect for the inherent worth of persons
The AIA complements the MDR/IVDR by introducing requirements to address hazards and risks for health, safety and fundamental rights specific to AI systems.
Introduction
screening score · 2026-10-23
Human Oversight
4/5Humans remain in control of consequential decisions
The AIA emphasizes the importance and sets a legal obligation on the manufacturer to design and develop AI systems, including high-risk MDAI, with appropriate human oversight mechanisms.
4. Transparency and human oversight
screening score · 2026-10-23
Privacy
2/5Protection of personal data and private life
The data governance and management practices, in the case of personal data, should be fully compliant with the GDPR provisions and include transparency about the original purpose of the data collection.
2. Data Governance
screening score · 2026-10-23
Transparency
4/5Openness about how AI systems work and are used
Under the AIA, transparency is a core requirement for high -risk MDAI. It introduces on providers a legally binding requirement to design and develop high-risk MDAI in such a way as to ensure that operation of high-risk MDAI is sufficiently transparent
4. Transparency and human oversight
screening score · 2026-10-23
Enforcement
4/5Consequences and compliance mechanisms with real force
In accordance with Article 43(4) of the AIA, high-risk MDAIs that have been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification
V. Substantial Modification/significant change
screening score · 2026-10-23
Impact Assessment
4/5Required assessment of an AI system's risks/impacts before or during use
The MDR and IVDR require manufacturers to validate MDAI outputs through rigorous testing in the form of clinical or performance evaluation to ensure compliance
III. Clinical /Performance Evaluation and Testing
screening score · 2026-10-23